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Recruiting NCT07208357

The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia

No phase Interventional Fibromyalgia Pregabalin Duloxetine Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pregabalin, Pregabalin with toludesvenlafaxine.
Who it may be relevant to
Registry conditions: Fibromyalgia, Pregabalin, Duloxetine, Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Toludesvenlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Overview

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of toludesvenlafaxine in FM. We hypothesize that the combination of pregabalin with toludesvenlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Interventions

  • Drug Pregabalin
    In the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily.
  • Drug Pregabalin with toludesvenlafaxine
    In the pregabalin with toludesvenlafaxine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. Toludesvenlafaxine will be administered at 40 mg daily initially. If the initial dose is well-tolerated, the dose could be further escalated by 40 mg per day after 7 days, up to a maximum of 160 mg per day. With each dose increase, AEs will be assessed and categorized as mild, moderate, or severe. If participants tolerate the current dose for 2 to 3 days, it will be m

Primary outcome measures

  • The average pain intensity [Time frame: At the 4-weeks]
Secondary outcome measures (7)
  • The worst pain intensity [Time frame: At the weeks 1, 2, 4, and 8]
  • The proportion of patients achieving pain reduction [Time frame: At the weeks 1, 2, 4, and 8]
  • The Revised FM Impact Questionnaire [Time frame: At the weeks 1, 2, 4, and 8]
  • The short-form 36 Health Survey (SF-36) [Time frame: t the weeks 1, 2, 4, and 8]
  • The Medical Outcomes Study Sleep Scale (MOS) [Time frame: At the weeks 1, 2, 4, and 8]
  • The Beck Depression Inventory-Ⅱ (BD-Ⅱ) [Time frame: At the weeks 1, 2, 4, and 8]
  • Adverse Events [Time frame: Through study completion, an average of 8 weeks]

Eligibility criteria

Inclusion criteria

  • Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
  • Aged 18 years or older;
  • Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
  • Numeric rating scale (NRS) score ≥ 4 at baseline;
  • Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
  • Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
  • Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Exclusion criteria

  • History of hypersensitivity to pregabalin, toludesvenlafaxine or any of its excipients;
  • History of epilepsy, or depression requiring antidepressant medications;
  • Pregnancy or breastfeeding;
  • Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
  • With acute or chronic pain conditions other than FM.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Identifiers

NCT: NCT07208357 · KY2025-217-03-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗